A new at-home low-level laser and light device boosts terminal hair counts in men and women with androgenetic alopecia with no reported side effects, according to recently released unpublished data looking at the iRestore Laser Hair Growth System (Freedom Laser Therapy).
The FDA-cleared iRestore device resembles a bicycle helmet and combines 21 5mW diode lasers (650 +/- 5nm) and 30 light-emitting diodes (LEDs).
Thirty-nine male and female patients, ages 18 to 60, with thinning hair or androgenetic alopecia, participated in the study. They weren’t taking other hair growth supplements or drugs at the time of the study.
Researchers selected and tattooed an area of up to 25 mm in diameter on each participant’s scalp, photographing it at baseline and 16 weeks post treatment. In the randomized, double-blinded study, patients received either the real iRestore helmet or a look-alike placebo helmet with regular red lights. They were instructed to wear the helmets 25 minutes at a time, every other day for 16 weeks.
Researchers report 100% of men and women using the iRestore laser helmet had hair regrowth at 16 weeks, with an average 43.23% increase in hair count, compared to 5.71% in the placebo group. Subjects in the active group experienced an average 37% increase in terminal hairs compared to placebo.
The authors write the protocol was well-tolerated, without producing toxicities.
“The role of the therapy as a maintenance treatment remains to be explored,” they write.
While the data suggests the iRestore kit, which retails for $695, treats hair loss without drugs or surgery, optimal treatment for these patients usually involves a combination approach, according to study investigator Adam B. Bodian, M.D., dermatologist and laser surgeon in Great Neck N.Y.
“Our study showed that the iRestore worked well by itself, but there’s no one treatment that works great alone,” Dr. Bodian says.
Dr. Bodian says he often combines an oral vitamin such as biotin or oral hormonal therapy in addition to topical therapy like minoxidil, and he recommends patients purchase a hair growth laser as the iRestore to use at home.
“I find everything works synergistically,” he says.
Best candidates for the iRestore, he says, are patients who still have at least some hair.
The device works, according to the company, because laser light energy enhances hair cells’ adenosine triphosphate production and the metabolism rate within hair follicles. The iRestore counteract androgenetic alopecia, extending the growth phase of the hair cycle and reactivating dormant hairs.
“Hair lasers, like the iRestore, have much greater growth success than combs or other devices because these other machines don’t deliver a consistent surface area or consistent laser energy to create enough equal and reproducible stimulation,” Dr. Bodian says.
Choosing the Right Device
Alan J. Bauman, M.D., a hair restoration surgeon in Boca Raton, Fla., who is not an investigator on the study, says questions remain on how the iRestore stacks up to other researched at-home laser devices for hair loss.
“On the spectrum of anecdotal reports, product trials and published peer-reviewed research, there are many levels of scientific rigor. When looking over this new study’s press release, however, I was disappointed to find little information provided on inclusion and exclusion criteria, which is especially important in female hair loss because there are so many contributing factors, as well as how the data was obtained, dosage calculated, etc. And no microphotos with each hair identified and counted were included in the release. It’s important from a scientific point of view to have this information for hair restoration physicians to interpret and to build upon to help our patients and design better studies in the future,” Dr. Bauman says.
Dr. Bauman says that he knows from treating thousands of patients with in-office and at-home laser therapy since the 1990s, that individual, real-world results come from accurate diagnoses, powerful and good quality lasers, as well as the tracking of results across the affected and at-risk zones of the scalp over time with a device like HairCheck (HairCheck), targeted micro-photos and standardized global photography.
The optimal way to guide hair loss patients about at-home treatment is that, generally, because laser devices are electronic in nature and there is so much competition in this market sector, you get what you pay for, according to Dr. Bauman.
“For example, some of the home devices contain higher numbers of laser diodes, which may deliver more areas of coverage…. Patients often say that advanced features, like discreet under-cap devices, which contain hundreds more laser diodes, give them more flexibility, comfort, larger treatment area and increased power delivery when dedicating their precious time to laser therapy,” he says. “One of the latest breakthroughs is the shorter treatment times of some of the more sophisticated, physician-prescribed/dispensed cap-devices like CapillusRX ( Capillus), [which is] as little as six minutes per day to receive the same FDA-cleared hair growth benefits with 312 diodes.”
The choice of a good laser therapy, Dr. Bauman says, can be a patient’s least costly treatment over time, since it’s typically a one-time expense lasting for many years, as opposed to ongoing medications or platelet-rich plasma (PRP) treatment.
Disclosure: Dr. Bodian has no conflicts other than he did the research. Dr. Bauman is on the speaker’s bureau for Church &Dwight, makers of Viviscal.